Kornimate/medical-research-clean huggingface dataset:
antineoplastons a10 and as2-1 in patients with carcinoma of the bladder

Conditions: Stage IV Bladder Cancer

Summary: current therapies for stage iv bladder cancer provide very limited benefit to the patient. the anti-cancer properties of antineoplaston therapy suggest that it may prove beneficial in the treatment of stage iv bladder cancer purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on patients with stage iv bladder cancer.

stage iv bladder cancer patients receive gradually escalating doses of intravenous antineoplaston therapy (atengenal + astugenal) until the maximum tolerated dose is reached. treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. objectives: * to determine the efficacy of antineoplaston therapy in patients with stage iv bladder cancer, as measured by an objective response to therapy (complete response, partial response or stable disease). * to determine the safety and tolerance of antineoplaston therapy in patients with stage iv bladder cancer. * to determine objective response, tumor size is measured utilizing mri scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility criteria:
inclusion criteria: * histologically confirmed stage iv bladder carcinoma that is unlikely to respond to existing therapy and for which no curative therapy exists or stage iv newly diagnosed, incurable bladder carcinoma * measurable disease by ct scan * tumor must be greater than 2 cm at the largest diameter for the lymph nodes located in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in the largest diameter for other localizations * 18 and over * karnofsky 60-100% * life expectancy: greater than 2 months * wbc at least 2,000/mm\^3 * platelet count at least 50,000/mm\^3 * bilirubin no greater than 2.5 mg/dl * sgot/sgpt no greater than 5 times upper limit of normal * no hepatic failure * creatinine no greater than 2.5 mg/dl * no history of renal conditions that contraindicate high dosages of sodium * no severe heart disease * no uncontrolled hypertension * no history of congestive heart failure * no history of other cardiovascular conditions that contraindicate high dosages of sodium * no severe lung disease * not pregnant or nursing * fertile patients must use effective contraception during and for 4 weeks after study participation * no serious active infections or fever * no other serious concurrent disease * at least 4 weeks since prior immunotherapy and recovered * no concurrent immunomodulating agents * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * concurrent corticosteroids allowed * at least 8 weeks since prior radiotherapy and recovered * recovered from any prior operative procedure * prior cytodifferentiating agent allowed exclusion criteria: - prior antineoplaston therapy

Keywords: recurrent bladder cancer
a study of investigational tirzepatide (ly3298176) doses in participants with type 2 diabetes and obesity

Conditions: Type 2 Diabetes; Obesity

Summary: the main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with type 2 diabetes and obesity that are already taking metformin. the study will last for about 89 weeks.

the study will include a screening period of up to 5 weeks. the primary endpoint will be at week 44 with a tirzepatide extension until week 80. a safety follow up will be performed approximately 4 weeks after end of treatment.

Eligibility criteria:
inclusion criteria * have a body mass index (bmi) ≥35 kilogram/square meter (kg/m²) at screening. * have had stable body weight (±5%) during the 90 days preceding screening. * have been diagnosed with type 2 diabetes (t2d). * have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day. exclusion criteria: * have type 1 diabetes (t1d), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except t2d. * have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening. * are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. * have a prior or planned surgical treatment for obesity. * use products intended for weight loss including prescription drugs, over the counter (otc) drugs, and herbal preparations, within 3 months prior to screening. * have renal impairment measured as estimated glomerular filtration rate (egfr) \<45 milliliter/min (ml/min)/1.73 m². * have any of the following cardiovascular (cv) conditions within 2 months prior to screening. * acute myocardial infarction. * cerebrovascular accident (stroke). * unstable angina . * hospitalization due to congestive heart failure, or * coronary artery revascularization. * have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (men) syndrome type 2. * have a history of chronic or acute pancreatitis.

Keywords: diabetes mellitus glucose metabolism disorders metabolic disease endocrine system diseases overnutrition nutrition disorders body weight tirzepatide incretins
remifentanil and glycemic response in cardiac surgery

Conditions: Heart Diseases; Hyperglycemia

Summary: this study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery to supress the hyperglycemic response in perioperative period. half of the participants will receive continuous intravenous remifentanil during surgery, while the other half will receive intermittent intravenous fentanyl during surgery. intermittent intravenous fentanyl administration is this institution's standard of care.

stress-induced hyperglycemia is a well-known phenomena that occurs during cardiopulmonary bypass surgery. hyperglycemia increases the incidence of major adverse events and mortality in patients undergoing cardiac surgery. remifentanil, an ultra-short acting opioid analgesic, has been shown to reduce the stress response to cardiopulmonary bypass when compared to intermittent fentanyl and inhalation anesthesia. this in turn, will reduce the occurence of perioperative hyperglycemia, glycemic variability and insulin requirements in patients undergoing cardiac surgery. note; primary outcome changed on 06/15/2015-change approved by university of pittsburgh irb on 06/22/2015- first patient enrolled january 2016. primary outcome measure; percentage of patients with two or more than two intraoperative blood glucose levels more than 180 mg% in both groups will be estimated and the difference in this parameter between the two groups will form the primary outcome measure of this study.

Eligibility criteria:
inclusion criteria: * open cardiac surgery through sternotomy approach (coronary artery bypass, valve surgery, and any other open heart surgeries) * surgery with use of cardiopulmonary bypass * patients over 18 years of age * both female and male genders * all races exclusion criteria: * minimally invasive heart surgery through thoracotomy approach * patients receiving regional analgesia such as intrathecal morphine * patients undergoing procedures under deep hypothermic circulatory arrest * patients with active infections such as acute infective endocarditis * emergency surgery * patients undergoing transplantations and ventricular assist device insertion * patients on any mechanical circulatory support preoperatively * patient's refusal * allergy to remifentanil * positive pregnancy test * morbid obesity * end stage liver and kidney disease

Keywords: cardiopulmonary bypass heart surgery
drug intensive monitoring study of olaparib in clinical practice among chinese patients

Conditions: Ovarian Cancer; Prostate Cancer

Summary: this is a multi-centre, prospective, non-interventional study. the study will enrol about 1,000 chinese cancer patients from around 56 sites. for oc cohort, the subjects who had received olaparib for at least one dose before study enrolment in real world practices will be enrolled ( n=800) . for pc cohort, according to the doctor's decision, patients who have prescribed and agreed to start taking at least one dose of olaparib will be enrolled ( n=200). patient's treating physician is in charge of prescribing (including dose-adjusting or interruption) or discontinuation of olaparib.

the study will enrol about 1,000 chinese cancer patients from around 56 sites. for oc cohort, the subjects who had received olaparib for at least one dose before study enrolment in real world practices will be enrolled ( n=800) . for pc cohort, according to the doctor's decision, patients who have prescribed and agreed to start taking at least one dose of olaparib will be enrolled ( n=200). patient's treating physician is in charge of prescribing (including dose-adjusting or interruption) or discontinuation of olaparib. the recruited patients will be followed up according to standard clinical practice. they will be tracked up to 30 days after discontinuation of olaparib treatment, or 6 months for cohort oc, 12 months for cohort pc after enrolment.every oc patient will be followed maximum of 6 months after enrolment as olaparib aes most occur in first 6m and pc patient will be followed maximum of 12 months to observe 1-year pfs. any adverse events (aes) that are ongoing at the patient's last visit in the study must be followed up by the investigator for as long as medically indicated, but without further recording in the electronic case report form (ecrf).

Eligibility criteria:
inclusion criteria * provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures * patients diagnosed as olaparib approved tumor types in china * eligible for olaparib treatment per the judgement of the treating physician in clinical practice * for oc cohort: at least take one tablet of olaparib before enrolment * for pc cohort: according to the doctor's decision, have prescribed and agreed to start taking at least one dose of olaparib exclusion criteria • in other ongoing studies, which prohibit any participation in this non-interventional study judged by investigator.

Keywords: oc and pc
once daily versus twice daily budesonide orodispersible tablets for induction of remission in eoe

Conditions: Eosinophilic Esophagitis

Summary: the purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets bid versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.


Eligibility criteria:
inclusion criteria: * signed informed consent, * male or female patients, 18 to 75 years of age, * confirmed clinico-pathological diagnosis of eosinophilic esophagitis (eoe) according to established diagnostic criteria * active symptomatic and histological eoe * negative pregnancy test in females of childbearing potential at baseline visit. exclusion criteria: * clinical and endoscopic signs of gastroesophageal reflux disease (gerd), * achalasia, scleroderma esophagus, or systemic sclerosis, * other clinically evident causes than eoe for esophageal eosinophilia, * any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\]), * any relevant systemic disease (e.g., aids, active tuberculosis, hepatitis b or c), * if careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection, * liver cirrhosis or portal hypertension, * history of cancer in the last five years, * history of esophageal surgery at any time or of esophageal dilation procedures within the last 4 weeks prior to screening visit, or need for an immediate endoscopic intervention due to a stricture * upper gastrointestinal bleeding within 8 weeks prior to baseline visit, * existing or intended pregnancy or breast-feeding.
qol assessment in cancer survivors integrated into routine clinical care

Conditions: Cancer

Summary: this observational cohort study of patients who received cancer treatment (of any modality) in the last 18 months are evaluated by the use of a validated qol tool (fact-gp) and are evaluated via telephone or in person or both. patients with high-risk for unmet needs or distress as determined by the fact-gp are referred to an in-person multidisciplinary cancer survivorship clinic. this is considered standard of care at the investigator's institution and is part of the continuous clinical quality improvement program within the geisinger cancer institute.


Eligibility criteria:
inclusion criteria: * diagnosis of malignancy in the last 18 months, treated with curative intent exclusion criteria: * patients treated with palliative intent, metastatic disease at the time of diagnosis

Keywords: survivorship
followup of glenoid fix utilizing auto bone graft in shoulder replacement

Conditions: Arthritis

Summary: this is a case study to evaluate the adequacy of fixation and functional outcome of the glenoid anchor peg following autologous bone grafting around the prosthesis at the time of implant.

to investigate if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlates with bony apposition on computed tomography scans, decreased radiolucent lines and component loosening, and functional outcomes. we hypothesize that by utilizing autologous bone graft from the resected humeral head, placed around the anchor peg glenoid prosthesis at implantation, there is a low incidence of glenoid loosening. we suggest that the absence of radiolucent lines correlated with excellent shoulder function.

Eligibility criteria:
inclusion criteria: * patients who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting from the investigator of this study will be recruited for this study. exclusion criteria: * patients will be excluded if they are unable to comprehend the consent information. * pregnant women will be excluded from this study.

Keywords: glenoid component radiolucent lines glenoid loosening glenohumeral arthritis autologous bone graft
adaptation of a cognitive training intervention for diabetes self-management

Conditions: Cognitive Function Abnormal; Diabetes Mellitus, Type 2

Summary: the aims of this project are: (1) to refine an existing cognitive rehabilitation intervention and tailor it for persons with t2dm by using current literature and interview data from 10 participants with t2dm and (2) to conduct a feasibility study of the adapted intervention with 20 participants with t2dm. the intervention consists of 8 weekly group educational sessions to teach compensatory cognitive strategies. participants will also use a web-based, game-like program to build on the didactic information and practice activities to improve cognitive health.

type 2 diabetes mellitus (t2dm) increases the risk for cognitive impairment and doubles the rate of cognitive decline after diabetes is diagnosed. in turn, the presence of cognitive dysfunction can make diabetes self-management more difficult. few interventions have attempted to focus on cognitive function in the context of diabetes and none, to date have tested an intervention to improve cognition in order to improve diabetes self-management. therefore the aims of this project are: (1) to refine an existing cognitive rehabilitation intervention and tailor it for persons with t2dm by using current literature and interview data from 10 participants with t2dm and (2) to conduct a feasibility study of the adapted intervention with 20 participants with t2dm. the intervention consists of 8 weekly group educational sessions to teach compensatory cognitive strategies. additionally, participants will use a web-based, game-like program to build on the didactic information and practice activities to improve cognitive health. the project will provide baseline data for further research on diabetes self-management in the context of cognitive dysfunction.

Eligibility criteria:
inclusion criteria: * age 40 to 70 * have been diagnosed with type 2 diabetes for at least 2 years * score of at least 10 on the perceived deficits questionnaire * read and write in english * have access to transportation and telephone and internet services exclusion criteria: * limitations that preclude study activities * have been diagnosed with dementia or disorders that can affect cognition such as depression * type 1 diabetes
multicenter study comparing ai-based navicam vs. conventional pillcam in small bowel pathology

Conditions: Small Intestine Disease

Summary: since its introduction in 2001, small bowel capsule endoscopy has been pivotal in diagnosing small bowel pathology due to its minimally invasive nature and high diagnostic accuracy. however, the technology has limitations, including prolonged reading times and the need for specialized endoscopists. the navicam endoscopic capsule, leveraging artificial intelligence (ai) with proscan™ for automated reading, promises to address these limitations by reducing reading times and enhancing diagnostic efficiency. this study aims to assess the diagnostic concordance and to compare the efficiency of the ai-based navicam capsule with the conventional pillcam sb3 in the exploration of the small bowel.

this is a prospective, multicenter, randomized, observational study involving multiple hospitals across spain. at each site, patients will ingest both the pillcam sb3 and navicam capsules in a randomized order. reading times, transit times, and diagnostic yield will be compared between the two devices. a central reading committee of experienced gastroenterologists will conduct blinded evaluations of both explorations using predefined criteria. the primary endpoint is the diagnostic concordance between navicam's ai-driven proscan™ system and the conventional reading of pillcam sb3, measured by cohen's kappa index. the secondary endpoints include to assess the correlation in lesion detection, video download times, gastric and small bowel transit times, total reading times, and adverse events. the sample size is 147 patients, accounting for an expected 10% dropout rate, based on previous studies showing a diagnostic concordance kappa index of 0.6. this study aims to establish that the ai-based navicam capsule is at least as effective as the conventional pillcam sb3 in diagnosing small bowel lesions, with potentially reduced reading times, thus enhancing clinical efficiency in small bowel diagnostics.

Eligibility criteria:
inclusion criteria: * outpatients over 18 years of age with any clinical indication to undergo a small bowel exploration using capsule endoscopy at the participating hospital. exclusion criteria: * patients with known small bowel strictures detected by computed tomography (ct) or magnetic resonance imaging (mri). * patients with a history of esophagogastric and small bowel surgery (excluding ileocecal resection). * patients with a clinical contraindication for small bowel capsule endoscopy. * hospitalized patients. * patients with pacemaker or implantable cardioverter defibrillator (icd). * patients scheduled for a mri within 15 days after capsule endoscopy ingestion. * pregnant or actively breastfeeding patients. * patients with swallowing disorders requiring endoscopic placement of the capsule. * simultaneous participation in another clinical trial using any investigational drug or device. * concurrent life-threatening pathology or condition. * inability to sign the informed consent form.

Keywords: capsule endoscopy artificial intelligence
counseling interventions for brca 1/2 cancer susceptibility testing

Conditions: Breast Cancer; Ovarian Cancer

Summary: to evaluate two different ways of providing information about genetic testing for brca1 and brca2 alterations. the two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.

* patients will have a blood sample drawn that will be analyzed for altered brca1 or brca2 genes. an alteration of brca1 or brca2 gene means there is an increased risk of developing breast and ovarian cancer. * patients participating in this study have either: 1) expressed an interest in testing for an underlying genetic factor that may account for the breast or ovarian cancer in their family; 2) have at least one relative that has been found to have a brca1 or brca2 alteration; 3) have a personal or family history of breast or ovarian cancer that is suggestive of a brca1 and brca2 alteration; or 4) has breast or ovarian cancer, or has at least one close relative with a history of breast or ovarian cancer and are a member of an ethnic group with increased frequency of brca1 and brca2 alterations. * patients will be randomized into one of two counseling groups. two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. these visits will be audio-taped to monitor how the project staff is covering the important information about testing. * throughout this study patients will be asked to complete questionnaires and psychological measures. these forms will be completed before and after the first visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and 12 months. * in addition 30 women will be asked to complete a 20-30 minute telephone interview with the program psychologist.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * member of a family in which a brca1 or brca2 deleterious germline mutation has been identified, whether or not the individual has had cancer herself; written documentation of the family mutation must be available for laboratory purposes during the testing process. * personal and/or family history of breast/ovarian/other cancer consistent with brca 1/2 heredity with posterior probability of carrying an altered gene * documentation of key family member cancer diagnoses is required exclusion criteria: * males, will be offered brca 1/2 testing through other protocols * individuals unable to speak or write english * already participated in a genetic counseling program for brca1 or brca2 testing * life expectancy of less than 12 months.

Keywords: genetic testing brca1 gene brca2 gene counseling interventions genetic counseling